VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1542775
Sex: F
Age: 39
State: ND

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Small dry patch; Rash (red, raised, hot); felt like my lymph nodes were inflamed; Armpit tenderness; My arm was sore; Brain fog; A spontaneous report was received from a healthcare professional, a 39 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced arm was sore, brain fog, armpit tenderness, felt like lymph nodes were inflamed, rash (red, raised, hot), and small dry patch. The patient's medical history was not provided. Concomitant product use was not provided. On 23 Dec 2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the right deltoid for COVID-19 infection prophylaxis. The patient stated that her arm was sore for and that it was not like any other soreness she had after receiving other shots. She reported that 3 hours after the shot she had brain fog. On 29 Dec 2020, the patient experienced armpit tenderness in the same arm she received the shot that lasted a week or more. She reported that it felt like her lymph nodes were inflamed. The patient stated she had an ultrasound and it was okay. On 04 Jan 2021, the patient developed a rash that was raised, red and hot. She stated that it was better but she still had a small, dry patch. Treatment for the events included triamcinolone. Traimcinolone included as treatment drug. Action taken with mRNA-1273 in response to the events was unknown. The brain fog, was considered resolved on 23 Dec 2020. The arm was sore, was considered resolved on 28 Dec 2020. The armpit tenderness and felt like my lymph nodes were inflamed, were considered resolved on an unknown date. The rash was considered resolving. The small dry patch, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542776
Sex: F
Age: 80
State: NY

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Severe amount of fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Severe amount of fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. No medical history was provided by the reporter. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient experienced FATIGUE (Severe amount of fatigue). At the time of the report, FATIGUE (Severe amount of fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1542777
Sex: F
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: fever; rigors; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1542778
Sex: F
Age: 33
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Sep-2020 and the estimated date of delivery was 17-Jun-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 28-Jan-2021, the patient experienced NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter). On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchiness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 29-Jan-2021, NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter) had resolved. At the time of the report, INJECTION SITE PRURITUS (itchiness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: events were added in the event tab.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1542779
Sex: M
Age: 70
State:

Vax Date: 01/16/2021
Onset Date: 01/09/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: twitching; pain; A spontaneous report was received from a non healthcare professional who was 70 years old male patient who received Moderna's COVID-19 vaccine. Caller reported adverse event following Moderna vaccine on 16JAN2021. Symptoms included twitching and pain. Patients medical history was not available. His concomitant medication included simvastatin for cholesterol,Tamsulosin for prostate and hydrochlorothiazide for water retention. The start date or stop date of these medications were not provided. Treatment provided was unknown. Action taken with mRNA -1273 was not available. The outcome of events ,twitching and pain are unknown.

Other Meds: SIMVASTATIN; TAMSULOSIN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1542780
Sex: F
Age: 37
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (sulfa drugs) and Allergy (mild environmental allergies). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication. On 27-Jan-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Nov-2020 and the estimated date of delivery was 13-Aug-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eleventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Pregnancy test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness: Drug allergy (sulfa drugs)

ID: 1542781
Sex: U
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Hypoglycaemia; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (Hypoglycaemia) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus insulin-dependent, Addison's disease, Pernicious anemia and Hashimoto's disease. On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Jan-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycaemia). At the time of the report, HYPOGLYCAEMIA (Hypoglycaemia) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: some of the medical history is added On 02-Feb-2021: No specific follow-up information recorded.; Sender's Comments: Although a temporal association exists, based on the current available information, mechanism of action of mRNA-1237 vaccine and the patient's concurrent condition of autoimmune polyendocrine syndrome, the event hypoglycemia is assessed as unlikely related.

Other Meds:

Current Illness: Addison's disease; Diabetes mellitus insulin-dependent

ID: 1542782
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Swelling under armpits; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling under armpits) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling under armpits). At the time of the report, LYMPHADENOPATHY (Swelling under armpits) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1542783
Sex: M
Age: 73
State: FL

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Developed Urticaria; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE URTICARIA (Developed Urticaria) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History was provided by the reporter. Concurrent medical conditions included Penicillin allergy. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Developed Urticaria). At the time of the report, INJECTION SITE URTICARIA (Developed Urticaria) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Penicillin allergy

ID: 1542784
Sex: F
Age: 54
State: TX

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: itching, red; itching, red; arm is swollen; Abdominal cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (itching, red), VACCINATION SITE ERYTHEMA (itching, red) and VACCINATION SITE SWELLING (arm is swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea) and VACCINATION SITE SWELLING (arm is swollen). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching, red) and VACCINATION SITE ERYTHEMA (itching, red). At the time of the report, ABDOMINAL PAIN (Abdominal cramps), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (itching, red), VACCINATION SITE ERYTHEMA (itching, red) and VACCINATION SITE SWELLING (arm is swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542785
Sex: F
Age: 68
State: DE

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: hives; fatigue; arm is hot; arm swollen and later csame in the news as Moderna Arm; Redness in the arm (dime-sized); Headache; Earache; Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Pain in arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Soy allergy, Shellfish allergy and Egg allergy. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced MYALGIA (Pain in arm). At the time of the report, MYALGIA (Pain in arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2021: No specific follow-up information recorded. On 23-Jun-2021: Non-Significant follow-up Appended

Other Meds:

Current Illness: Shellfish allergy; Soy allergy

ID: 1542786
Sex: F
Age: 69
State: IA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Injection site was warm; Red circle around the injection site; Injection site perhaps a little bit raised; injection wite like a mosquito bite, wanted to scratch because it was itchy; Injection site a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesteraemia. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm). At the time of the report, VACCINATION SITE WARMTH (Injection site was warm) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant drug included cholesterol medicine. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-JUN-2021 contains non-significant information.

Other Meds: ADVIL [IBUPROFEN]

Current Illness: Hypercholesteraemia

ID: 1542787
Sex: F
Age: 83
State: TX

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen a little bit), PYREXIA (fever), AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen a little bit) and PYREXIA (fever). On 16-Jan-2021, the patient experienced AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell). On 15-Jan-2021, VACCINATION SITE SWELLING (arm was swollen a little bit) and PYREXIA (fever) had resolved. At the time of the report, AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1542788
Sex: F
Age: 62
State: MA

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Itching; Burning; Redness; Headache; Nausea; Fever; Fatigue; Achiness; Soreness in that arm; Stiffness in that arm; Swelling of her neck and groin lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching), BURNING SENSATION (Burning), VACCINATION SITE ERYTHEMA (Redness), HEADACHE (Headache) and NAUSEA (Nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), BURNING SENSATION (Burning), VACCINATION SITE ERYTHEMA (Redness), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Achiness), PAIN IN EXTREMITY (Soreness in that arm), MUSCULOSKELETAL STIFFNESS (Stiffness in that arm) and LYMPHADENOPATHY (Swelling of her neck and groin lymph nodes). At the time of the report, VACCINATION SITE PRURITUS (Itching), BURNING SENSATION (Burning), VACCINATION SITE ERYTHEMA (Redness), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Achiness), PAIN IN EXTREMITY (Soreness in that arm), MUSCULOSKELETAL STIFFNESS (Stiffness in that arm) and LYMPHADENOPATHY (Swelling of her neck and groin lymph nodes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1542789
Sex: F
Age: 55
State: TX

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Headache; Diarrhea; Chills; Pressure went high; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIARRHOEA (Diarrhea), CHILLS (Chills) and HYPERTENSION (Pressure went high) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (Headache), DIARRHOEA (Diarrhea), CHILLS (Chills) and HYPERTENSION (Pressure went high). At the time of the report, HEADACHE (Headache), DIARRHOEA (Diarrhea), CHILLS (Chills) and HYPERTENSION (Pressure went high) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1542790
Sex: M
Age: 74
State: PA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: fluid came out of injection site; A spontaneous report was received from a consumer concerning a male patient who received Modern's COVID-19 vaccine (mRNA-1273) and as soon the needle was removed from the injection site, fluid came out, not blood, pink fluid. The patient's medical history was reported as cancer for 18years. Relevant concomitant medications reported were Finasteride 5 mcg and Tamsulosin 0.4mcg. 26-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) for prophylaxis of COVID-19 infection, as soon the needle was removed from the injection site, fluid came out, not blood, pink fluid, so the provider cleaned that and after the fluid continues going out and provider cleaned again. No Laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. At the time of this report, the outcome of the event injection site extravasation is Unknown.

Other Meds: FINASTERIDE; TAMSULOSIN

Current Illness:

ID: 1542791
Sex: F
Age: 75
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: itching everywhere; bad trembles and could not stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (bad trembles and could not stop shaking) and PRURITUS (itching everywhere) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 (experienced trembles and could not stop shaking). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced TREMOR (bad trembles and could not stop shaking). On an unknown date, the patient experienced PRURITUS (itching everywhere). At the time of the report, TREMOR (bad trembles and could not stop shaking) and PRURITUS (itching everywhere) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The patient was treated with Benadryl (diphenhydramine) for the itching.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542792
Sex: M
Age: 40
State: TX

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Pain in the arm; Whole body hurts; Blurred vision; Chills; Fever 100.7; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), PAIN (Whole body hurts), VISION BLURRED (Blurred vision), CHILLS (Chills) and PYREXIA (Fever 100.7) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), PAIN (Whole body hurts), VISION BLURRED (Blurred vision), CHILLS (Chills), PYREXIA (Fever 100.7) and MYALGIA (Muscle aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm), PAIN (Whole body hurts), VISION BLURRED (Blurred vision), CHILLS (Chills), PYREXIA (Fever 100.7) and MYALGIA (Muscle aches) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542793
Sex: F
Age: 60
State: IL

Vax Date: 01/05/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: brown faded circle at injection site; minor itching; 1.5in redness at site of injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCOLOURATION (brown faded circle at injection site), PRURITUS (minor itching) and VACCINATION SITE ERYTHEMA (1.5in redness at site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast cancer (patient is scheduled to have Breast cancer surgery next month.). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (minor itching) and VACCINATION SITE ERYTHEMA (1.5in redness at site of injection). On 18-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (brown faded circle at injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (brown faded circle at injection site) and VACCINATION SITE ERYTHEMA (1.5in redness at site of injection) outcome was unknown and PRURITUS (minor itching) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Breast cancer (patient is scheduled to have Breast cancer surgery next month.)

ID: 1542794
Sex: F
Age: 75
State: FL

Vax Date: 01/06/2021
Onset Date: 01/10/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: red at the injection site; Rash at the site of shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the site of shot) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination. The patient's past medical history included Breast cancer (her lymph nodes were taken out) and Lymph node excision. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulpher), Drug allergy (Codeine), Tremor and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE for Acid reflux (esophageal), NADOLOL and TOPIRAMATE (TOPAMAX) for Tremor. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the site of shot). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site). The patient was treated with ACETAMINOPHEN at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site rash, at a dose of UNK dosage form. On 15-Jan-2021, VACCINATION SITE RASH (Rash at the site of shot) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red at the injection site) had resolved. Not Provided Reportedly, diphenhydramine and antihistaminic were rubbed on the site of shot and rash on the site of shot Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Additional information received included: reporter details, Patient demographic details, Medical history, concomitant medication, Vaccination dates, lot# event start date, stop date, outcome and treatment details.

Other Meds: NADOLOL; TOPAMAX; ESOMEPRAZOLE

Current Illness: Drug allergy (Sulpher); Drug allergy (Codeine); Penicillin allergy

ID: 1542795
Sex: F
Age: 77
State: FL

Vax Date: 01/12/2021
Onset Date: 01/18/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039U20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1542796
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Red rash around the deltoid area with a bullseye appearance; Injection site was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash around the deltoid area with a bullseye appearance) and VACCINATION SITE PAIN (Injection site was tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE RASH (Red rash around the deltoid area with a bullseye appearance) and VACCINATION SITE PAIN (Injection site was tender). At the time of the report, VACCINATION SITE RASH (Red rash around the deltoid area with a bullseye appearance) and VACCINATION SITE PAIN (Injection site was tender) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1542797
Sex: F
Age: 78
State: FL

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: big red itchy circle about 2 inches; big red itchy circle about 2 inches; arm is still swollen; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (big red itchy circle about 2 inches), ERYTHEMA (big red itchy circle about 2 inches) and PERIPHERAL SWELLING (arm is still swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. Previously administered products included for an unreported indication: Flu vaccine (she gets big red itchy circle from flu vaccine). On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (big red itchy circle about 2 inches), ERYTHEMA (big red itchy circle about 2 inches) and PERIPHERAL SWELLING (arm is still swollen). At the time of the report, PRURITUS (big red itchy circle about 2 inches), ERYTHEMA (big red itchy circle about 2 inches) and PERIPHERAL SWELLING (arm is still swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1542798
Sex: F
Age: 70
State: FL

Vax Date: 01/02/2021
Onset Date: 01/09/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: pale; itchiness; redness 4-4.5 inches in diameter around the injection site; swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), INJECTION SITE ERYTHEMA (redness 4-4.5 inches in diameter around the injection site), INJECTION SITE SWELLING (swelling around the injection site) and PALLOR (pale) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ANTIBIOTICS for Rosacea, LEVOTHYROXINE SODIUM (SYNTHROID), SPIRONOLACTONE and GABAPENTIN for an unknown indication. On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (itchiness), INJECTION SITE ERYTHEMA (redness 4-4.5 inches in diameter around the injection site) and INJECTION SITE SWELLING (swelling around the injection site). On 18-Jan-2021, the patient experienced PALLOR (pale). On 15-Jan-2021, INJECTION SITE SWELLING (swelling around the injection site) had resolved. At the time of the report, PRURITUS (itchiness) and INJECTION SITE ERYTHEMA (redness 4-4.5 inches in diameter around the injection site) had not resolved and PALLOR (pale) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included hydrocortisone cream 3-4 times a day for a week

Other Meds: SYNTHROID; SPIRONOLACTONE; ANTIBIOTICS; GABAPENTIN

Current Illness:

ID: 1542799
Sex: F
Age:
State: MD

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Diarrhea; Stomach hurting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL PAIN (Stomach hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN (Stomach hurting). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL PAIN (Stomach hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1542800
Sex: F
Age: 87
State: TX

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Fever; Chills; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and PAIN (Soreness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Soreness). On 20-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and PAIN (Soreness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included Tylenol

Other Meds:

Current Illness:

ID: 1542801
Sex: M
Age: 67
State: FL

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: flush in face; flu like symptoms; mild sinus congestion; lightheaded; chills with rigors; fatigue; low grade fever 99.8 f; This spontaneous case was reported by a physician and describes the occurrence of FLUSHING (flush in face), INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS CONGESTION (mild sinus congestion), DIZZINESS (lightheaded) and CHILLS (chills with rigors) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced FLUSHING (flush in face), INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS CONGESTION (mild sinus congestion), DIZZINESS (lightheaded), CHILLS (chills with rigors), FATIGUE (fatigue) and PYREXIA (low grade fever 99.8 f). On 13-Jan-2021, FLUSHING (flush in face), INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS CONGESTION (mild sinus congestion), DIZZINESS (lightheaded), CHILLS (chills with rigors), FATIGUE (fatigue) and PYREXIA (low grade fever 99.8 f) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Treatment included Ibuprofen and Tylenol

Other Meds:

Current Illness:

ID: 1542802
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/17/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Arm got all inflamed; Arm got swollen; Arm got all itchy; Arm got all red; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Arm got all inflamed), PERIPHERAL SWELLING (Arm got swollen), PRURITUS (Arm got all itchy) and ERYTHEMA (Arm got all red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced INFLAMMATION (Arm got all inflamed), PERIPHERAL SWELLING (Arm got swollen), PRURITUS (Arm got all itchy) and ERYTHEMA (Arm got all red). At the time of the report, INFLAMMATION (Arm got all inflamed), PERIPHERAL SWELLING (Arm got swollen) and ERYTHEMA (Arm got all red) outcome was unknown and PRURITUS (Arm got all itchy) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542803
Sex: F
Age: 37
State: TX

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. Concomitant products included OMEGA-3 FATTY ACIDS and pre natal vitamins for an unknown indication. On 28-Jan-2021 at 9:05 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Sep-2020 and the estimated date of delivery was 05-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the seventeenth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: OMEGA-3 FATTY ACIDS; pre natal vitamins

Current Illness:

ID: 1542804
Sex: M
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: became a little tired after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (became a little tired after the vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (became a little tired after the vaccination). At the time of the report, FATIGUE (became a little tired after the vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Non-significant follow-up appended. Reporter does not remember reporting an event for her brother-in-law

Other Meds:

Current Illness:

ID: 1542805
Sex: F
Age: 40
State: CA

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Sweating; Burning in chest; Felt cold like vapor rub on arm; Feeling weak today; Pain in my arm; Burning in arms; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), CHEST PAIN (Burning in chest), FEELING COLD (Felt cold like vapor rub on arm), ASTHENIA (Feeling weak today) and PAIN IN EXTREMITY (Pain in my arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), CHEST PAIN (Burning in chest), FEELING COLD (Felt cold like vapor rub on arm), ASTHENIA (Feeling weak today), PAIN IN EXTREMITY (Pain in my arm) and BURNING SENSATION (Burning in arms). At the time of the report, HYPERHIDROSIS (Sweating), CHEST PAIN (Burning in chest), FEELING COLD (Felt cold like vapor rub on arm), ASTHENIA (Feeling weak today), PAIN IN EXTREMITY (Pain in my arm) and BURNING SENSATION (Burning in arms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021:Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1542806
Sex: F
Age: 65
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: red, itchy lesion on the injection site which progressed to become raised, very hard squarish; red, itchy lesion on the injection site which progressed to become raised, very hard squarish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) and VACCINATION SITE ERYTHEMA (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) and VACCINATION SITE ERYTHEMA (red, itchy lesion on the injection site which progressed to become raised, very hard squarish). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) and VACCINATION SITE ERYTHEMA (red, itchy lesion on the injection site which progressed to become raised, very hard squarish) had resolved. Concomitant medications were not provided. Patient did not experience any adverse reaction after second dose of vaccine. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Event outcome and action taken updated.

Other Meds:

Current Illness:

ID: 1542807
Sex: F
Age: 57
State: VA

Vax Date: 01/02/2021
Onset Date: 01/04/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (hotness at the vaccination site), INJECTION SITE ERYTHEMA (redness at the vaccination site), INJECTION SITE PRURITUS (itchiness at the vaccination site), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LEVOTHYROXINE, ATENOLOL, LORATADINE (CLARITINE) and SALBUTAMOL SULFATE (Pro Air INHALERIN) for an unknown indication. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (hotness at the vaccination site), INJECTION SITE ERYTHEMA (redness at the vaccination site), INJECTION SITE PRURITUS (itchiness at the vaccination site), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain). At the time of the report, INJECTION SITE PAIN (hotness at the vaccination site), INJECTION SITE ERYTHEMA (redness at the vaccination site), INJECTION SITE PRURITUS (itchiness at the vaccination site), MYALGIA (Muscle Pain) and ARTHRALGIA (joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included topical cream, Advil to take 2 times daily, once in the morning and once at night until hotness is gone. Antibiotics

Other Meds: LEVOTHYROXINE; ATENOLOL; CLARITINE; Pro Air INHALERIN

Current Illness:

ID: 1542808
Sex: F
Age: 44
State: ME

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: sweating; a little bruising at the injection site; feel foggy; heavy breathing; sore on the vaccination site; Tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), INJECTION SITE BRUISING (a little bruising at the injection site), FEELING ABNORMAL (feel foggy), DYSPNOEA (heavy breathing) and INJECTION SITE PAIN (sore on the vaccination site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013O20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Artificial sweetener intolerance (Allergic to artificial sugar.(Sucrose)). On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), INJECTION SITE BRUISING (a little bruising at the injection site), FEELING ABNORMAL (feel foggy), DYSPNOEA (heavy breathing), INJECTION SITE PAIN (sore on the vaccination site), FATIGUE (Tired) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweating), INJECTION SITE BRUISING (a little bruising at the injection site), FEELING ABNORMAL (feel foggy), DYSPNOEA (heavy breathing), INJECTION SITE PAIN (sore on the vaccination site), FATIGUE (Tired) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness: Artificial sweetener intolerance (Allergic to artificial sugar.(Sucrose))

ID: 1542809
Sex: F
Age: 33
State: TX

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included Miscarriage (ectopic) in May 2019, Alcohol use (very minimal) in May 2019 and Miscarriage (blighted ovum) in October 2019. Concurrent medical conditions included Drug hypersensitivity, Hypothyroidism since April 2010, Food allergy and Penicillin allergy. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Jul-2020 and the estimated date of delivery was 05-May-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-sixth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2020, Pregnancy test: positive (Positive) Positive. On 04-Nov-2020, Prenatal screening test: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Ultrasound was done at 5, 7, 10 and 20 weeks. Glucose screening was scheduled on 03-Feb-2021. Estimated date of conception was on 12-Aug-2020. Treatment medications were not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: LEVOTHYROXINE; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness: Drug hypersensitivity; Food allergy; Hypothyroidism; Penicillin allergy

ID: 1542810
Sex: F
Age: 63
State: CA

Vax Date: 01/06/2021
Onset Date: 01/18/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 06-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE ERYTHEMA (red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.

Other Meds: BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1542811
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: fever; body aches; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical History). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542812
Sex: M
Age: 75
State: AL

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Bad Diarrhea; His stomach feels a little queasy; This spontaneous case was reported by an other caregiver and describes the occurrence of DIARRHOEA (Bad Diarrhea) and NAUSEA (His stomach feels a little queasy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIARRHOEA (Bad Diarrhea) and NAUSEA (His stomach feels a little queasy). At the time of the report, DIARRHOEA (Bad Diarrhea) and NAUSEA (His stomach feels a little queasy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1542813
Sex: F
Age: 74
State: NY

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: about one-half hour later, she experienced a minimal sore arm; minimal soreness is off and on and ongoing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing). At the time of the report, PAIN IN EXTREMITY (about one-half hour later, she experienced a minimal sore arm) and PAIN (minimal soreness is off and on and ongoing) had resolved. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: FU-1 is added and the outcome of events are updated.

Other Meds:

Current Illness:

ID: 1542814
Sex: F
Age: 71
State: TX

Vax Date: 01/06/2021
Onset Date: 01/10/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Headache; Redness at injection site; Itching at the injection site; Chills; fever of 107; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever of 107), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever of 107). On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itching at the injection site). On 18-Jan-2021, the patient experienced HEADACHE (Headache). On 10-Jan-2021, CHILLS (Chills) and PYREXIA (fever of 107) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542815
Sex: F
Age: 93
State: FL

Vax Date: 01/17/2021
Onset Date: 01/18/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: nausea; hard time trying to eat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 103L20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm). At the time of the report, NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1542816
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: have redness around the injection site; it feels hot; little bit hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (have redness around the injection site), VACCINATION SITE WARMTH (it feels hot) and VACCINATION SITE INDURATION (little bit hard) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (have redness around the injection site), VACCINATION SITE WARMTH (it feels hot) and VACCINATION SITE INDURATION (little bit hard). At the time of the report, VACCINATION SITE ERYTHEMA (have redness around the injection site), VACCINATION SITE WARMTH (it feels hot) and VACCINATION SITE INDURATION (little bit hard) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1542817
Sex: M
Age: 74
State: LA

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: headache; coughing at night; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and COUGH (coughing at night) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Headache and Coughing. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and COUGH (coughing at night). At the time of the report, HEADACHE (headache) and COUGH (coughing at night) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness: Coughing; Headache

ID: 1542818
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: facial swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (facial swelling) and HEADACHE (headache). At the time of the report, SWELLING FACE (facial swelling) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 contains NNI On 26-Jul-2021: Follow up received on 26-Jul-2021 and contains no new information.

Other Meds:

Current Illness:

ID: 1542819
Sex: F
Age:
State:

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Arm was swollen; woke up with terrible chills that lasted 45-60 minutes; Her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Her arm was sore), PERIPHERAL SWELLING (Arm was swollen) and CHILLS (woke up with terrible chills that lasted 45-60 minutes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced ARTHRALGIA (Her arm was sore). On 18-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen) and CHILLS (woke up with terrible chills that lasted 45-60 minutes). At the time of the report, ARTHRALGIA (Her arm was sore), PERIPHERAL SWELLING (Arm was swollen) and CHILLS (woke up with terrible chills that lasted 45-60 minutes) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1542820
Sex: F
Age: 56
State: NY

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Redness at the injection site; Throat felt thick; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat felt thick) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PHARYNGEAL SWELLING (Throat felt thick). On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). On 18-Jan-2021, PHARYNGEAL SWELLING (Throat felt thick) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new information received.

Other Meds:

Current Illness:

ID: 1542821
Sex: F
Age:
State: CA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: big fat lip; light bloody nose; bad dizziness; muscle ache; fatigue; pain and sore over the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache), FATIGUE (fatigue), LIP SWELLING (big fat lip), EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Jan-2021 at 5:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (pain and sore over the injection site). On 06-Jan-2021, the patient experienced MYALGIA (muscle ache) and FATIGUE (fatigue). On 07-Jan-2021, the patient experienced LIP SWELLING (big fat lip), EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Jan-2021 for Lip swelling, at an unspecified dose and frequency. On 07-Jan-2021, MYALGIA (muscle ache) had resolved. On 08-Jan-2021, EPISTAXIS (light bloody nose) and DIZZINESS (bad dizziness) had resolved. At the time of the report, FATIGUE (fatigue), LIP SWELLING (big fat lip) and INJECTION SITE PAIN (pain and sore over the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1542822
Sex: M
Age: 77
State: NY

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: sense of smells vastly enhanced; pain at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Loss of smell in 2019, Hearing loss in 2019 and Taste loss in 2019. On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications used were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542823
Sex: F
Age: 66
State: WA

Vax Date: 01/08/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: widwly spread reaction in the arm up to the elbow; wide spread reaction at the injection site, redness and itching of the arm; wide spread reaction at the injection site, redness and itching of the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (wide spread reaction at the injection site, redness and itching of the arm), VACCINATION SITE PRURITUS (wide spread reaction at the injection site, redness and itching of the arm) and ADVERSE REACTION (widwly spread reaction in the arm up to the elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Low blood pressure. Concomitant products included LISINOPRIL for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (wide spread reaction at the injection site, redness and itching of the arm) and VACCINATION SITE PRURITUS (wide spread reaction at the injection site, redness and itching of the arm). On 17-Jan-2021, the patient experienced ADVERSE REACTION (widwly spread reaction in the arm up to the elbow). At the time of the report, VACCINATION SITE ERYTHEMA (wide spread reaction at the injection site, redness and itching of the arm), VACCINATION SITE PRURITUS (wide spread reaction at the injection site, redness and itching of the arm) and ADVERSE REACTION (widwly spread reaction in the arm up to the elbow) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment drug included Tylenol and benadryl; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LISINOPRIL

Current Illness:

ID: 1542824
Sex: F
Age: 55
State: TX

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: a lot of headache; fever; nausea; vomit; dilation of the genitals; tingling on her arms and legs; pain in the abdominal area; pain in the legs; a lot of muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a lot of headache), PYREXIA (fever), CHILLS (chills), ABDOMINAL PAIN (pain in the abdominal area) and PAIN IN EXTREMITY (pain in the legs) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypothyroidism, Type 2 diabetes mellitus, Hypertension and High cholesterol. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, GEMFIBROZIL, ROSUVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills) and MYALGIA (a lot of muscle pain). On 17-Jan-2021, the patient experienced ABDOMINAL PAIN (pain in the abdominal area), PAIN IN EXTREMITY (pain in the legs), GENITALS ENLARGED (dilation of the genitals) and PARAESTHESIA (tingling on her arms and legs). On 18-Jan-2021, the patient experienced HEADACHE (a lot of headache), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomit). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 18-Jan-2021, CHILLS (chills), ABDOMINAL PAIN (pain in the abdominal area), PAIN IN EXTREMITY (pain in the legs), MYALGIA (a lot of muscle pain), GENITALS ENLARGED (dilation of the genitals) and PARAESTHESIA (tingling on her arms and legs) had resolved. At the time of the report, HEADACHE (a lot of headache), NAUSEA (nausea) and VOMITING (vomit) outcome was unknown and PYREXIA (fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment provided was Ibuprofen and Acetaminophen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SYNTHROID; METFORMIN; GEMFIBROZIL; ROSUVASTATIN; HYDROCHLOROTHIAZIDE; LOSARTAN; ASPIRIN 81

Current Illness: High cholesterol; Hypertension; Hypothyroidism; Type 2 diabetes mellitus

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm